NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

Sure is...  Exactly right. That quote reflects the legal reality under SI 2025 No. 87, not a hypothetical.

Before SI 87, the MHRA’s Specials framework allowed one-off use of unlicensed medicines, but it wasn’t designed for personalized cell therapies like DCVax-L. It didn’t support decentralized production, kit-based combinations, or cross-border logistics.

Now it does.
SI 87 formally allows:

• Patient-specific ATMP kits (like DCVax-L + Hiltonol) to be manufactured and delivered without full MHRA approval, so long as each dose is labeled for a named patient.

• Modular manufacturing, closed-loop devices like Flaskworks can now be deployed across sites under a single Control Site license.

• Combination delivery, DCVax + Poly-ICLC, G100, or Decoy can be paired in real time without triggering new authorizations.

• Export and return, tumor tissue can be shipped to a licensed facility (like Sawston), and cryopreserved vaccine returned for injection.

• Named-patient labeling not a brand, just a person.

That’s what this system is built around.

So yes, the regulatory model no longer requires traditional approval for what DCVax is already doing under Specials.

This isn’t a workaround.It’s codified law.

And it’s already live.

Now ask yourself (God forbid), if you or your loved one had stage 4 metastatic carcinoma that was inoperable and 100% lethal, would you be willing to pay out of pocket?

got DCVax?